a study of elranatamab (pf-06863135) in chinese participants with refractory multiple myeloma.

Conditions: Elranatamab; Myeloma; Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma; PF-06863135; BCMA; Bispecific; Bispecific Antibody; BCMA-CD3 Bispecific; MagnetisMM-8

Summary: the purpose of this study is to understand the study medicine (called elranatamab, or pf-06863135) as potential treatment for refractory multiple myeloma. multiple myeloma is a form of cancer in the bone that forces healthy blood cells to go out. sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma. elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. we are seeking chinese participants to take part in this study. the study will be 2 parts, called part 1b and part 2. in part 1b, participants will receive elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. we will monitor participants' safety and reactions to the study medicine. this will help us understand the dosage of elranatamab to be used safely. in part 2 of the study, participants will receive elranatamab and their multiple myeloma growth will be monitored. this will help us understand if elranatamab, when used alone, may be a therapy for refractory multiple myeloma. participants in this part of the study are expected to take part for about 2 years.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma (imwg criteria, rajkumar et al, 2014) * measurable disease, as defined by at least 1 of the following: * serum m-protein ≥0.5 g/dl * urinary m-protein excretion ≥200 mg/24 hours * serum immunoglobulin flc ≥10 mg/dl (≥100 mg/l) and abnormal serum immunoglobulin kappa to lambda flc ratio * refractory to at least one imid * refractory to at least one pi * refractory to at least one anti-cd38 antibody * relapsed/refractory to last anti-myeloma regimen * ecog performance status ≤2 * adequate bm function characterized by the following: 1. absolute neutrophil count ≥1.0 × 10\^9/l 2. platelets ≥ 25 × 10\^9/l 3. hemoglobin ≥8 g/dl * resolved acute effects of any prior therapy to baseline severity or ctcae grade ≤1 * not pregnant and willing to use contraception exclusion criteria: * smoldering multiple myeloma * active plasma cell leukemia * amyloidosis * poems syndrome * stem cell transplant or active gvhd within 12 weeks prior to enrollment. * previous treatment with an anti-bcma directed therapy * impaired cardiovascular function or clinically significant cardiovascular diseases * ongoing grade ≥2 peripheral sensory or motor neuropathy. history of gbs or gbs variants, or history of any grade ≥3 peripheral motor polyneuropathy. * active hbv, hcv, sars-cov2, hiv, or any active, uncontrolled bacterial, fungal, or viral infection * any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. * previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Keywords: multiple myeloma neoplasms, plasma cell neoplasms by histologic type neoplasms hemostatic disorders vascular diseases cardiovascular diseases paraproteinemias blood protein disorders hematologic diseases hemorrhagic disorders lymphoproliferative disorders immunoproliferative disorders immune system diseases